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Comparison of Single-Visit Endodontic Treatment Outcomes Using Continuous Wave Condensation and Single-Cone Obturation Techniques

2026年4月24日 更新者:Nguyen Thi Nhat Vy、Hue University of Medicine and Pharmacy

Comparison of Single-Visit Endodontic Treatment Outcomes Using Continuous Wave Condensation and Single-Cone Obturation Techniques: A Randomized Clinical Trial

The goal of this clinical trial is to compare two root canal obturation techniques for endodontic treatment in patients aged 15 to 56 years with irreversible pulpitis. The main questions it aims to answer are:

  1. Does continuous wave condensation differ from the single-cone technique in obturation time?
  2. Does continuous wave condensation differ from the single-cone technique in obturation quality, postoperative pain, and 6-month treatment success? Researchers will compare continuous wave condensation with single-cone obturation to see whether one technique provides better sealing quality, shorter treatment time, less postoperative pain, or higher clinical success.

Participants will:

  • Receive endodontic treatment for teeth diagnosed with irreversible pulpitis.
  • Undergo root canal preparation with Reciproc Blue R25.
  • Have canals obturated using either continuous wave condensation or the single-cone technique.
  • Be evaluated for obturation time, radiographic quality immediately after treatment, postoperative pain at 4, 24, 48, and 72 hours, and clinical-radiographic outcome at 6 months.

調査の概要

詳細な説明

Background and Rationale: Irreversible pulpitis requires endodontic treatment to eliminate infection, prevent reinfection, and preserve tooth function. Effective three-dimensional obturation of the root canal system (RCS) is critical for long-term success. The single-cone (SC) technique offers procedural simplicity and reduced chair time but may compromise adaptation to complex canal anatomy. Continuous wave condensation (CWC) uses thermoplasticized gutta-percha to improve sealing of lateral canals and isthmuses. Despite widespread clinical use, comparative clinical data on obturation time, radiographic quality, postoperative pain, and short-term outcomes remain limited, particularly in irreversible pulpitis cases without periapical pathology.

Study Design:

This single-center, superiority, parallel-group randomized clinical trial compared CWC and SC obturation techniques in 60 teeth from 54 patients. Randomization occurred at the tooth level (1:1 allocation) using sequentially numbered opaque sealed envelopes. Operators (two calibrated endodontists) were unblinded due to technique differences; radiographic and clinical assessors remained blinded.

Interventions:

All teeth underwent standardized single-visit treatment under local anesthesia:

Root Canal Preparation (both groups): (1) Access cavity preparation, (2) Working length determination (apex locator + radiograph), (3) Cleaning/shaping with Reciproc Blue R25 reciprocating files (VDW, Germany) using step-down technique, (4) Final irrigation: 3% NaOCl (5 mL per canal), EDTA (17%, 3 min), saline rinse

  • CWC Group (EQ-V system, Meta Biomed, South Korea): (1) Master cone fit verified radiographically. (2) EQ-V cutting tip positioned 4-6 mm short of working length; cone tip trimmed 0.5-1 mm. (3) Master cone + sealer inserted: Heated plugger activated (230°C) to apical 4-6 mm compaction --> Hand plugger vertical condensation --> Thermoplasticized gutta-percha backfill --> Post-obturation radiograph
  • SC Group: (1) Master cone fit verified radiographically. (2) Cone coated with sealer, seated to working length. (3) Excess gutta-percha is heat-trimmed at the orifice. (4) Post-obturation radiograph

Sealer: AH Plus (Dentsply Sirona) in both groups. Obturation time is measured from cone insertion to radiograph completion.

Outcome Assessments:

  • Primary: 6-month success (European Society of Endodontology criteria: no symptoms + normal/reduced PDL space)
  • Secondaries:

    • Obturation time (stopwatch, seconds)
    • Radiographic quality (length: adequate/short/long; voids; sealer extrusion; accessory canal filling)
    • Pain (NRS 0-10 at 4, 24, 48, 72 hours)

Assessor: Independent blinded evaluator (NTNV)

Follow-up: Patients are recalled at 6 months (±2 weeks) for clinical exam and radiograph. Success determined by absence of pain/swelling/sinus tract + radiographic healing.

Statistical Considerations:

Sample size calculated for 80% power (α=0.05, P1=89.5% vs P2=77.0% canal filling rates). Intention-to-treat analysis. Continuous data: independent t-tests. Categorical: chi-square/Fisher's exact. p<0.05 significant.

研究の種類

介入

入学 (実際)

56

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Hue
      • Huế、Hue、ベトナム、49000
        • Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy, Hue University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Teeth diagnosed with irreversible pulpitis
  • Indicated for endodontic treatment
  • Patients aged 18-60 years

Exclusion Criteria:

  • Periapical/furcation lesions;
  • Need for periodontal surgery
  • Periodontal pockets ≥ 5 mm
  • Adjacent teeth undergoing endodontic treatment
  • Severely fractured or non-restorable crowns
  • Immature/abnormal roots
  • Internal or external resorption
  • Calcified/C-shaped canals
  • Canal curvature >70°
  • Failures during canal preparation

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:CWC
Continuous Wave Condensation (EQ-V system, Meta Biomed): Heated plugger at 230°C, apical compaction, thermoplastic backfill.

Continuous Wave Condensation (CWC) - Specific Protocol:

  • EQ-V system (Meta Biomed, South Korea) - NOT System B, Touch'n Heat, or generic pluggers
  • Precise heat activation: 230°C (manufacturer setting for optimal flow)
  • Cutting tip positioned 4-6 mm short of working length (prevents over-compaction)
  • Gutta-percha cone tip pre-trimmed 0.5-1 mm (ensures precise apical control)
  • Two-stage process: apical hand condensation + thermoplastic backfill
  • Time measured from cone insertion to final radiograph (includes verification)
アクティブコンパレータ:SC
Single-Cone: Gutta-percha cone + sealer to working length, heat trim excess.
  • Matched master cone to Reciproc Blue R25 preparation (size/exact tug-back)
  • Heat trimming at/below orifice (minimizes coronal excess vs cold cutting)
  • NO supplementary cones or lateral compaction (pure single-cone)
  • Sealer: AH Plus (Dentsply) - not bioceramic or other brands

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
The rate of 6-month treatment success
時間枠:6 months
clinical/radiographic per European Society of Endodontology criteria
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Obturation time
時間枠:from insertion of master gutta-percha cone with sealer until completion of obturation procedure (final condensation/backfill completed)
from insertion of master gutta-percha cone with sealer until completion of obturation procedure (final condensation/backfill completed)
Percentage of canals with adequate obturation length (±2 mm from radiographic apex) assessed by periapical radiograph
時間枠:Immediately post-obturation, within 5 minutes after the obturation procedure is completed.
Assessment was performed per tooth (n=60) and per canal (n=193) by a blinded independent assessor. The length of canal filling was classified as adequate obturation length (Gutta-percha at radiographic apex or <2 mm short), underfilled (Gutta-percha >2 mm short of apex), or overfilled (Gutta-percha beyond radiographic apex).
Immediately post-obturation, within 5 minutes after the obturation procedure is completed.
Percentage of canals/tooth with the presence of voids (radiolucency within filling material) assessed by periapical radiograph
時間枠:Immediately post-obturation: within 5 minutes after the obturation procedure is completed.

The presence of voids within obturation material assessed by periapical radiograph is classified as:

  1. Void presence: Radiolucency observed within the obturation material
  2. Void absence: No radiolucency detected
Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
Percentage of canals/tooth with apical sealer/gutta-percha extrusion (material beyond radiographic apex) assessed by periapical radiograph
時間枠:Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
The apical sealer and gutta-percha extrusion, which extends beyond the radiographic apex, were assessed using a periapical radiograph and classified as yes/no extrusion.
Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
Percentage of tooth with the presence of gutta-percha filling in accessory/lateral canals assessed by periapical radiograph
時間枠:Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
Periapical radiographs assess the presence of gutta-percha filling in accessory/lateral canals, classifying it as yes/no accessory canal filling.
Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
Postoperative pain intensity assessed by Numeric Rating Scale (NRS 0-10)
時間枠:4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation
Patient-reported pain severity on 11-point NRS (0=no pain, 10=worst imaginable pain). Assessed at four time points by patient diary.
4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年6月1日

一次修了 (実際)

2024年12月1日

研究の完了 (実際)

2025年6月1日

試験登録日

最初に提出

2026年4月15日

QC基準を満たした最初の提出物

2026年4月24日

最初の投稿 (実際)

2026年5月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月1日

QC基準を満たした最後の更新が送信されました

2026年4月24日

最終確認日

2024年12月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • H2022/259

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

As this study was completed prior to institutional data sharing policy implementation at Hue University of Medicine and Pharmacy, individual participant data (IPD) sharing is undecided. De-identified patient data includes sensitive clinical records (radiographs, pain scores, demographics) from a Vietnamese university hospital population.

Sharing requires Institutional Review Board (IRB) re-approval (H2022/259), participant re-consent (not obtained at enrollment), and Vietnamese Ministry of Health data protection compliance. Technical limitations include lack of standardized electronic health record format and absence of data use agreements with international repositories.

Researchers may contact the corresponding author (ntnvy@huemed-univ.edu.vn) to discuss potential collaboration. Aggregate results are fully reported in the primary publication. IPD sharing decisions will follow institutional policy updates and applicable regulations including GDPR-equivalent Vietnamese personal data

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